2024 年4 月3 日 医药: 超配 证券研究报告 / 业绩点评报告 翰森制药 (3692 HK, 买入, 目标价: HK$19.91) 自主研发和 BD 合作推动公司业绩稳健增长 目标价: HK$19.91 当前股价: HK$15.48 • 创新药收入增长和对外授权收入使得公司2023 年利润增速快速增长。 股价上行/下行空间 +29% 52周最高/最低价 (HK$) 17.24/9.41 • 自主研发和BD 合作形成差异化管线布局。 市值 (US$mn) 11,701 • 维持买入，将DCF 目标价上调至HK$19.91 (WACC: 9.1%)。 当前发行数量(百万股) 5,916 三个月平均日交易額 11 2023 年创新药收入保持快速增长：根据公司公告，2023 实现营收/ 归母净利润 101.4 亿 (US$mn) 流通盘占比 (%) 41 元 / 32.8 亿元，同比+7.7%/ 26.9%。其中，医药产品的销售收入为94 亿元，同比+1.1%。 主要股东 (%) 创新药收入同比增加37.1%至68.7 亿元，占公司总收入的比例上升至67.9%（2022 年为 Stellar Infinity ...

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 22.85 per share, compared to the current price of HKD 15.48 [4]. Core Views - The company reported a revenue of HKD 10.104 billion for 2023, representing a year-on-year growth of 7.7%. The net profit reached HKD 3.278 billion, up 26.9%, with operating cash flow of HKD 3.116 billion, an increase of 13.7% [2]. - The company has accelerated innovation and internationalization, with 7 new drugs approved for market, contributing to a sales revenue of HKD 6.865 billion from innovative drugs and collaborative products, which is a 37.1% increase and accounts for 67.9% of total revenue [2]. - Research and development (R&D) expenditure for 2023 was HKD 2.097 billion, a 23.8% increase, representing 20.8% of revenue. The company has over 30 innovative pipelines in clinical development [2]. Summary by Sections Financial Performance - Revenue for 2023 was HKD 10.104 billion, with a growth rate of 7.7%. The net profit was HKD 3.278 billion, reflecting a growth of 26.9% [3]. - The earnings per share (EPS) for 2023 was HKD 0.55, with projections for 2024 and 2025 at HKD 0.68 and HKD 0.59 respectively [3]. R&D and Innovation - The company has 30+ innovative pipelines in clinical development, focusing on expanding the treatment potential of its core pipeline, Amivantamab [2]. - The company has entered into two licensing agreements with GSK, which could yield upfront payments of USD 85 million and USD 185 million [2]. Market Position and Future Outlook - The report indicates that the company's innovative products are expected to continue unlocking market potential, with core pipelines showing global competitiveness in clinical treatment capabilities [2]. - The projected EPS for 2024-2026 is expected to be HKD 0.68, HKD 0.59, and HKD 0.71 respectively, with a reasonable value derived from a risk-adjusted DCF method being HKD 22.85 per share [2].

Investment Rating - The report assigns a "Buy" rating to the company, with a target price raised to HKD 17.90, indicating a potential upside of 15.6% from the current price of HKD 15.48 [4][6]. Core Insights - The company achieved a revenue increase of 7.7% year-on-year in 2023, reaching RMB 10.14 billion. Excluding milestone revenues, pharmaceutical product sales grew by 1.1% to RMB 9.40 billion, with innovative drug sales surging by 37.1% to RMB 6.87 billion, now constituting 67.9% of total revenue [2][3]. - The management anticipates steady revenue growth from 2024 to 2026, with a projected CAGR of 12.3%. Key drivers include strong sales growth of the oncology drug Amelotex and the hepatitis B drug Hengmu, both showing robust demand despite a challenging industry environment [3][4]. - The company is expected to receive a USD 185 million upfront payment for ADC drug HS-20093 from GSK in 2024, along with potential milestone payments based on development progress [3]. Financial Summary - The company reported a gross profit increase of 6.5% to RMB 9.07 billion in 2023, with a reduction in sales expense ratio from 37.8% to 34.9%. Net profit attributable to shareholders rose by 26.9% to RMB 3.28 billion, exceeding expectations [2][4]. - Revenue forecasts for 2024 and 2025 have been slightly adjusted upwards by 0.04% and 0.1%, respectively, reflecting the positive performance in 2023 [3][4]. - The financial outlook includes projected revenues of RMB 9.38 billion, RMB 10.10 billion, RMB 12.05 billion, RMB 13.66 billion, and RMB 14.29 billion for the years 2024E to 2026E, with corresponding growth rates of 7.7%, 19.3%, 13.3%, and 4.6% [5][10].

Investment Rating - The report maintains a Neutral rating for the company with a target price of HKD 16.00, indicating a potential upside of 7.5% from the current price of HKD 14.88 [2][7]. Core Insights - The company reported a revenue growth of 7.7% year-on-year for FY23, reaching RMB 10.104 billion, driven by a 37.1% increase in innovative drugs and collaboration products, which now account for 67.9% of total revenue [1][4]. - Net profit for FY23 increased by 26.9% to RMB 3.278 billion, exceeding expectations due to a gross margin of 89.8% and significant increases in bank interest and investment income [1][4]. - The company expects product sales growth to recover to double digits in FY24, with innovative drug revenue projected to exceed 70% of total revenue [1][2]. Financial Summary - Revenue projections for FY24 are set at RMB 12.310 billion, reflecting a 21.8% growth, with net profit expected to reach RMB 3.991 billion, a 21.6% increase [4][6]. - The company plans to double its capital expenditure from RMB 200 million in the previous year to invest in R&D headquarters [1]. - Key therapeutic areas such as oncology and metabolic diseases showed strong performance, with revenue growth of 11.7% and 16.3%, respectively [1][4]. Research and Development Focus - The company will focus on key products such as Amelot, ADC, and GLP-1 dual-target drugs in 2024, with plans to submit a supplemental NDA for Amelot in Q3 2024 [1][2]. - The sales target for Amelot is projected to exceed RMB 6 billion by 2026, despite a 40% price reduction due to insurance negotiations [1][4].

Financial Performance - The company reported a revenue of approximately RMB 10.104 billion for the year ending December 31, 2023, representing a growth of about 7.7% compared to the previous year[1]. - Profit for the year was approximately RMB 3.278 billion, reflecting a growth of about 26.9% compared to the previous year[1]. - Earnings per share were approximately RMB 0.55, an increase of about 26.6% from the previous year[1]. - Gross profit for the same period was RMB 9,072.943 million, up from RMB 8,515.400 million in the previous year, indicating a gross margin improvement[38]. - The company reported a total comprehensive income of RMB 3,705.424 million for the year, compared to RMB 3,216.633 million in 2022, marking an increase of approximately 15.2%[39]. - The company achieved a net profit of RMB 3,277.503 million for the year, compared to RMB 2,583.747 million in 2022, reflecting a year-over-year increase of approximately 27%[39]. - The company's income tax expense for 2023 was RMB 488,652,000, an increase of 34.1% from RMB 364,681,000 in 2022[50]. - The company declared a total dividend of approximately RMB 652,843,000 for 2023, compared to RMB 713,265,000 in 2022, reflecting a decrease of 8.5%[51]. Revenue Breakdown - Sales revenue from innovative drugs and collaborative products reached approximately RMB 6.865 billion, an increase of about 37.1%, accounting for approximately 67.9% of total revenue, up from 53.4% in the previous year[1]. - The revenue from the oncology segment was approximately RMB 6.169 billion, accounting for about 61.0% of total revenue[10]. - The revenue from the anti-infection segment was approximately RMB 1.269 billion, accounting for about 12.6% of total revenue[10]. - Revenue from customer contracts and product sales amounted to RMB 9,403,962 thousand, up from RMB 9,298,594 thousand in the previous year[47]. Research and Development - Research and development expenses were approximately RMB 2.097 billion, a growth of about 23.8%, representing about 20.8% of total revenue[1]. - The company has over 30 innovative drug projects at various stages of research and development, indicating a strong pipeline for future growth[9]. - The company plans to continue expanding its innovative drug portfolio and has several clinical trials underway for new treatments[3]. - The company is conducting over 50 clinical trials across more than 30 innovative drug products, with eight new drugs entering clinical stages in mainland China during the reporting period[24]. Product Approvals and Collaborations - The company received approval for six new products during the reporting period, including one innovative drug with two approved indications[2]. - The company has a total of seven innovative drugs approved for listing, all included in the National Medical Insurance Catalogue[2]. - The company entered into an exclusive cooperation agreement with Antengene Corporation for the commercialization of selinexor in mainland China[4]. - The company developed a new drug, HS-20105, which received clinical trial approval for the treatment of advanced solid tumors[5]. - The company received clinical trial approval for the innovative drug HS-10511, intended for the treatment of hypertrophic cardiomyopathy (HCM)[6]. - The company entered into a licensing agreement with GSK for the global exclusive rights to develop, manufacture, and commercialize HS-20089, a novel B7-H4 targeted antibody-drug conjugate (ADC)[6]. Market Presence and Strategy - The company plans to continue expanding its market presence in China, where over 90% of its revenue is generated[45]. - The company aims to achieve carbon neutrality by 2055 and has enhanced its environmental goals for 2030[31]. - The company plans to enhance innovation and accelerate the commercialization of R&D outcomes to meet unmet medical needs in China and globally[37]. Financial Position and Assets - As of December 31, 2023, the company had cash and bank deposits of RMB 22.435 billion, an increase from RMB 17.615 billion in the previous year[33]. - The company's debt-to-asset ratio was approximately 21.9% as of December 31, 2023, down from 24.5% the previous year[33]. - Total assets as of December 31, 2023, were RMB 25,794,773 thousand, compared to RMB 22,646,944 thousand in 2022, reflecting a growth of 13.5%[41]. - Non-current liabilities decreased to RMB 381,457 thousand from RMB 4,735,433 thousand, indicating a substantial reduction[41]. Employee and Governance - The company had a total of 9,123 employees as of December 31, 2023, with employee costs amounting to approximately RMB 2,681.81 million for the year[36]. - The company has adopted a corporate governance code and believes it has complied with all relevant provisions during the reporting period, except for the separation of roles between the chairman and CEO[62]. - The audit committee, consisting of three independent non-executive directors, reviewed the audited results for the year ending December 31, 2023, ensuring compliance with accounting principles[65]. Shareholder Information - The company issued 11,000,000 new shares under the restricted share unit plan at an issue price of HKD 2.29 per share, with the market price on the previous trading day being HKD 14.96[36]. - The proposed final dividend for the year ending December 31, 2023, is HKD 0.1422 per share, significantly higher than HKD 0.05 per share in 2022, marking a 184.4% increase[66]. - The company suspended share transfer registration from June 21, 2024, to June 25, 2024, to determine shareholder eligibility for the proposed final dividend[67].

《科创板日报》3月15日讯（记者 郑炳巽）一系列动作显示，翰森制药（3692.HK）正加速在创新药领域的布局。 14日晚间，翰森制药透露全资附属公司已经与普米斯生物技术（珠海）有限公司（下称“普米斯”）签订协议，获得对方的独家许可，有权在全球范围内开发、生产及商业化所引进的双抗ADC（抗体偶联药物）产品HS-20117/PM1080，翰森制药方面将支付包括首付款及里程碑付款等在内的最高潜在付款50亿元。 《科创板日报》记者查询发现，此次实际是翰森制药与普米斯就HS-20117/PM-1080产品达成的进一步合作，在此之前，翰森制药针对该产品从普米斯所获得的开发及商业化许可范围，仅限于在中国内地及港澳台地区。翰森制药表示，本次新增许可将进一步丰富在研管线。 目前，国家药监局已经批准HS-20117/PM-1080的临床试验，I期临床研究正在进行之中，拟用于治疗晚期实体瘤。但翰森制药并未透露，许可范围扩大后是否将启动海外同步临床。 翰森制药近年来正频繁引进创新药产品，而与普米斯的合作也仅是其中之一。 在2023年8月，翰森制药旗下公司江苏豪森从德琪医药（6996.HK）引进塞利尼索（selinexor），开展在中 ...

智通财经APP获悉，翰森制药(03692)现涨近5%，截至发稿，涨4.59%，报12.76港元，成交额2341.59万港元。 消息面上，翰森制药发布公告，HS-10398胶囊已获得中国国家药品监督管理局核准签发的临床试验通知书，拟用于治疗免疫球蛋白A肾病和膜性肾病；HS-10501片已获得中国国家药品监督管理局核准签发的临床试验通知书，拟用于治疗2型糖尿病和成人肥胖症；HS-10509片已获得中华人民共和国国家药品监督管理局核准签发的临床试验通知书，拟用于治疗精神分裂症。 此外，据市场消息称，2月5日，国家医保局向有关行业协会发布关于征求《关于建立新上市化学药品首发价格形成机制鼓励高质量创新的通知(征求意见稿)》意见的函件。业内人士表示，此举在于鼓励药品创新研发，有利于保护医药企业创新积极性，也是对之前谈判采购政策的完善。 ...

Financial Performance - The company recorded an unaudited revenue of approximately RMB 4.511 billion for the six months ended June 30, 2023, representing a year-on-year growth of approximately 1.7%[14] - The company's profit was approximately RMB 1.289 billion, a decrease of approximately 0.7% compared to the same period last year[14] - Basic earnings per share were approximately RMB 0.22, down approximately 0.8% year-on-year[14] - The total revenue for the same period was approximately RMB 4.511 billion, an increase of about 1.7% year-on-year, while profit was approximately RMB 1.289 billion, a decrease of about 0.7% year-on-year[21] - The net profit for the first half of 2023 was RMB 1,288,848 thousand, slightly down from RMB 1,297,976 thousand in the same period of 2022, a decrease of about 0.7%[95] - The total comprehensive income for the first half of 2023 was RMB 1,752,778 thousand, compared to RMB 1,551,525 thousand in 2022, showing an increase of approximately 12.9%[95] - The company reported a foreign exchange gain of RMB 463,930 thousand for the first half of 2023, significantly higher than RMB 253,549 thousand in 2022, indicating a growth of about 83.0%[95] Research and Development - Research and development expenses amounted to approximately RMB 929 million, an increase of approximately 25.8% year-on-year, representing about 20.6% of total revenue[14] - The company has a total of 1,617 R&D personnel and over 30 innovative drug projects at various clinical stages as of June 30, 2023[19] - The company is focusing on enhancing its innovation capabilities through licensing and collaborative development in the global pharmaceutical industry[19] - The company emphasizes the development of innovative drugs with a focus on safety and efficacy, aiming to provide advanced treatment options for various diseases[33] - The company has successfully transformed into an innovative biopharmaceutical company focused on the development and sales of innovative drugs[15] - The company is actively pursuing new product development in the oncology sector, particularly targeting chronic myeloid leukemia (CML) and non-small cell lung cancer (NSCLC)[181] Product Development and Approvals - The company has received approval for seven innovative drugs, with six included in the national medical insurance catalog as of June 30, 2023[15] - Four new products were approved for market launch during the reporting period, including one innovative drug[15] - The innovative drug Amelot has been recognized in multiple national treatment guidelines and has received a patent award for its invention[25] - The innovative drug Saint Luolai (培莫沙肽注射液) received approval for two indications related to anemia caused by CKD in June 2023, enhancing treatment compliance with a longer half-life[31] - The company obtained clinical trial approvals for several innovative drugs, including HS-10390 for focal segmental glomerulosclerosis and HS-10506 for depression and insomnia[36] - The company is preparing for the submission of marketing authorization applications (MAA) for new therapies[181] Financial Position and Cash Flow - As of June 30, 2023, the company reported a net cash inflow from operating activities of RMB 1.146 billion for the six months ended[44] - The company's cash and bank deposits stood at RMB 16.917 billion as of June 30, 2023, down from RMB 17.615 billion on December 31, 2022[44] - The company's asset-liability ratio was approximately 24.3% as of June 30, 2023, slightly down from 24.5% on December 31, 2022[44] - The company reported a significant increase in share-based payment expenses to RMB 86,225 thousand from RMB 51,194 thousand, indicating higher compensation costs[101] - The company reported a net loss from associates of RMB 2,123,000 for the six months ended June 30, 2023, compared to a loss of RMB 776,000 in the same period of 2022[127] Shareholder Information and Corporate Governance - As of June 30, 2023, the company had a total of 5,933,350,070 shares issued, with major shareholders holding significant stakes[55] - Trust influential persons held 3,900,000,000 shares, representing 65.73% of the total shares[55] - The company has not made any significant investments or acquisitions during the reporting period and continues to seek strategic investment opportunities[48][49] - The company has complied with all corporate governance code provisions except for the separation of the roles of Chairman and CEO[79] - The company’s restricted share unit plan was approved on May 27, 2019, and is valid for ten years[63] Market Strategy and ESG Initiatives - The company was recognized in the S&P Global "Sustainable Development Yearbook (China Edition)" with an ESG rating in the top 1% of the industry[17] - The company is focused on environmental, social, and governance (ESG) initiatives to enhance its corporate responsibility[177] - The company plans to enhance R&D investments and strengthen technology accumulation to accelerate the development and commercialization of self-researched and introduced products[52] - The company remains committed to operational transformation and improving operational efficiency while adhering to compliance policies for sustainable development[52]

Financial Performance - For the six months ended June 30, 2023, the company reported revenue of approximately RMB 4.511 billion, an increase of about 1.7% compared to the same period last year[1]. - The company's profit was approximately RMB 1.289 billion, a decrease of about 0.7% compared to the same period last year[1]. - The basic earnings per share were approximately RMB 0.22, a decrease of about 0.8% year-on-year[1]. - Total revenue for the same period was approximately RMB 4.511 billion, an increase of about 1.7% year-on-year, while profit was approximately RMB 1.289 billion, a decrease of about 0.7% year-on-year[6]. - The group's profit before tax reached RMB 1,301,181,000 for the six months ended June 30, 2023, compared to RMB 1,236,688,000 for the same period in 2022, reflecting an increase of approximately 5.2%[40]. - The total income tax expense for the group was RMB 211,035,000 for the six months ended June 30, 2023, compared to RMB 211,148,000 for the same period in 2022, showing a slight decrease[42]. - The group declared a dividend of HKD 0.05 per share for the fiscal year 2022, totaling approximately RMB 268,852,000, compared to RMB 455,826,000 for the previous year[43]. - The group experienced a significant increase in employee benefits expenses, totaling RMB 1,301,181,000 for the six months ended June 30, 2023, compared to RMB 1,236,688,000 for the same period in 2022, an increase of approximately 5.2%[40]. Research and Development - Research and development expenses amounted to approximately RMB 929 million, an increase of about 25.8% year-on-year, accounting for approximately 20.6% of total revenue[1]. - The company has successfully transformed into an innovative biopharmaceutical company focused on the development and sales of innovative drugs, with seven innovative drugs approved for listing as of June 30, 2023[2]. - The company has a total of 1,617 R&D personnel and over 30 innovative drug projects at various clinical stages as of June 30, 2023[6]. - The company has established a comprehensive R&D platform and has developed multiple innovative drug products, indicating a strong focus on innovation and technology advancement[36]. - The company is committed to expanding its R&D team and investing in technology[64]. - The company plans to continue increasing R&D investment and strengthen its technological capabilities to accelerate the development and commercialization of self-developed and introduced products[29]. Innovative Drug Sales - Sales revenue from innovative drugs reached approximately RMB 2.786 billion, representing a year-on-year growth of about 20.1%, with the proportion of revenue from innovative drugs rising from 52.3% to 61.8%[1]. - For the six months ended June 30, 2023, the company's innovative drug sales revenue was approximately RMB 2.786 billion, representing a year-on-year growth of about 20.1% and accounting for 61.8% of total revenue[6]. - Revenue from the oncology drug portfolio reached approximately RMB 2.555 billion, accounting for about 56.6% of total revenue[7]. - Revenue from the anti-infection drug portfolio was approximately RMB 601 million, representing about 13.3% of total revenue[7]. - Revenue from the central nervous system disease drug portfolio was approximately RMB 701 million, accounting for about 15.5% of total revenue[7]. - Revenue from the metabolic and other areas reached approximately RMB 654 million, representing about 14.6% of total revenue[7]. Market Position and Strategy - The company has established a leading position in major therapeutic areas with significant unmet medical needs, including oncology and central nervous system diseases[2]. - The recent policy adjustments in the national medical insurance catalog are expected to enhance the accessibility and commercial potential of innovative drugs, benefiting companies with high clinical value and effective commercialization capabilities[5]. - The company is committed to expanding its market presence, particularly in the Chinese pharmaceutical market, where over 90% of its revenue and operating profit are generated[37]. Corporate Governance and ESG - The company was included in the S&P Global's "Sustainable Development Yearbook (China Edition)" with an ESG rating in the top 1% of the industry, receiving the "Best Progress Company" award[4]. - The company aims to enhance its ESG management and has been recognized as one of the "Best 1%" and "Best Progress in Industry" in the S&P Global Corporate Sustainability Assessment for 2022[24]. - The company has complied with all corporate governance code provisions except for the separation of the roles of Chairman and CEO, which are currently held by the same individual[51]. Financial Position - As of June 30, 2023, the company had cash and bank deposits totaling RMB 16.917 billion, with financial assets at fair value through profit or loss amounting to RMB 4.530 billion[25]. - The company's debt-to-asset ratio was approximately 24.3% as of June 30, 2023, showing a slight decrease from 24.5% at the end of 2022[25]. - The company's total assets less current liabilities as of June 30, 2023, amounted to RMB 24,526,398 thousand, down from RMB 27,382,377 thousand as of December 31, 2022[32]. - The company's net assets amounted to RMB 24,175,628,000, an increase from RMB 22,646,944,000 as of December 31, 2022, representing a growth of approximately 6.75%[33]. - The total non-current liabilities decreased significantly to RMB 350,770,000 from RMB 4,735,433,000, indicating a reduction of approximately 92.59%[33]. Shareholder Information - The company issued and allocated 11,000,000 new shares under the Restricted Share Unit Plan, with a total of 20,304,400 restricted share units granted during the six months ended June 30, 2023[28]. - The average number of ordinary shares issued for basic earnings per share calculation was 5,923,743,166 for the six months ended June 30, 2023, slightly up from 5,916,956,923 for the same period in 2022[46]. - The company declared an interim dividend of HKD 0.0707 per share for the six months ended June 30, 2023, compared to HKD 0.0500 per share for the same period in 2022, representing a 41.4% increase[55]. Investment and Funding - The company issued USD 600 million zero-coupon convertible bonds due in 2026, with net proceeds of approximately USD 595.65 million allocated primarily for R&D expenses, facility upgrades, and general corporate purposes[60]. - The company has fully utilized the net proceeds from its 2019 IPO for the intended purposes as disclosed in the prospectus[56]. - The company plans to fully utilize the remaining proceeds from the bond issuance by 2030[61]. - The company has drawn down 4.8316 billion USD from the convertible bond issuance, with 1.0849 billion USD remaining unutilized[65]. Clinical Trials and Approvals - Four new products were approved for market during the reporting period, including one innovative drug, and eleven new clinical trial approvals were obtained for six innovative drugs[2]. - Clinical trials for HS-10365 and HS-20093 presented promising results at major conferences, showing good safety profiles and anti-tumor activity in various cancer types[18]. - The company has obtained clinical trial approvals for several new drugs, including HS-10390 for focal segmental glomerulosclerosis and IgA nephropathy, HS-10506 for depression and insomnia, HS-20117 for advanced solid tumors, HS-10516 for renal cell carcinoma, and HS-10518 for endometriosis-related pain and heavy menstrual bleeding[20][21][22][23].

Innovative Drug Development and Approvals - Hansoh Pharmaceutical's innovative drug sales revenue reached approximately RMB 5.006 billion, a year-on-year increase of 19.1%, accounting for 53.4% of the company's total revenue, up from 42.3% in the same period last year[4] - The company has successfully transformed into an innovative biopharmaceutical company, with five Class 1 innovative drugs and one imported innovative drug approved for marketing in China, all included in the National Medical Insurance Directory[4] - In 2022, the company obtained 19 clinical approvals, all related to innovative drugs, and submitted six marketing applications, including one for an innovative drug[4] - The company's Class 1 innovative drug, Ameile (Aumolertinib), was approved for first-line treatment of EGFR-mutated non-small cell lung cancer in December 2021[6] - In 2022, the company received clinical trial approvals for three new Class 1 drugs targeting chronic myeloid leukemia, advanced solid tumors, and schizophrenia[6] - The company's innovative drug Hengmu (Tenofovir Alafenamide Fumarate Tablets) was included in the 2021 National Medical Insurance Directory[6] - The company's innovative drug "Xinyue" (Inebilizumab Injection) received drug registration approval from the National Medical Products Administration in March 2022[7] - The company presented Phase I trial data for its self-developed PI3Kα inhibitor HS-10352 at the 2022 AACR Annual Meeting, showing promising anti-tumor activity in HR+HER2- advanced breast cancer patients with PIK3CA mutations[7] - The company obtained clinical trial approvals for two self-developed Class 1 new drugs: HS-10386 for advanced solid tumors and HS-10384 for menopausal vasomotor syndrome in April 2022[7] - The company's partner EQRx submitted the first MAA for Aumolertinib (a third-generation EGFR-TKI) outside China to the MHRA in June 2022[7] - The company received drug registration approval for Palbociclib Capsules, an anti-tumor drug for HR+HER2- advanced breast cancer, in July 2022[7] - The company's self-developed Class 1 new drug HS-10390 tablets received clinical trial approval from the National Medical Products Administration in January 2023, intended for the treatment of focal segmental glomerulosclerosis and IgA nephropathy[100] - The company's Class 1 new drug HS-10517 tablets, a 3CL protease inhibitor for COVID-19, also received clinical trial approval in January 2023, targeting mild to moderate adult COVID-19 patients[100] - Four innovative drugs (including new indications) were included in the 2022 edition of the National Reimbursement Drug List in January 2023: Ameile®, Xinyue®, Haosen Xinfu®, and Fulaimi®[100] - Ameile® was newly included in the National Reimbursement Drug List for the first-line treatment of NSCLC patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations[100] - Xinyue® was newly included in the National Reimbursement Drug List for the treatment of AQP4 antibody-positive NMOSD in adults[100] Financial Performance - Revenue for 2022 was approximately RMB 9.382 billion, a decrease of 5.6% year-over-year[19][21] - Net profit for 2022 was approximately RMB 2.584 billion, a decrease of 4.8% year-over-year[19][21] - Net profit margin remained stable at 27.5%, maintaining a high level in the industry[19] - Sales revenue from innovative drugs reached approximately RMB 5.006 billion, accounting for 53.4% of total revenue, up from 42.3% in the previous year[19][21] - Revenue for 2022 was RMB 9,382,410 thousand, a decrease of 5.6% compared to RMB 9,935,141 thousand in 2021[143] - Gross profit for 2022 was RMB 8,515,400 thousand, a decrease of 6.1% compared to RMB 9,065,099 thousand in 2021[143] - Net profit for 2022 was RMB 2,583,747 thousand, a decrease of 4.8% compared to RMB 2,712,902 thousand in 2021[143] - Total comprehensive income for 2022 was RMB 3,216,633 thousand, an increase of 28.1% compared to RMB 2,511,499 thousand in 2021[144] - Cash and bank balances increased to RMB 17,615,274 thousand in 2022, up from RMB 14,702,056 thousand in 2021[145] - Total assets less current liabilities increased to RMB 27,382,377 thousand in 2022, up from RMB 24,136,441 thousand in 2021[145] - Total equity attributable to owners of the parent company increased to RMB 22,646,944 thousand in 2022, up from RMB 20,028,845 thousand in 2021[146] - R&D expenses for 2022 were RMB 1,693,314 thousand, a decrease of 5.8% compared to RMB 1,797,012 thousand in 2021[143] - Other comprehensive income for 2022 was RMB 632,886 thousand, compared to a loss of RMB 201,403 thousand in 2021[144] - Non-current assets increased to RMB 4,170,259 thousand in 2022, up from RMB 3,980,803 thousand in 2021[145] - Total equity increased from RMB 17,875,598 thousand in 2021 to RMB 22,646,944 thousand in 2022, reflecting a growth of 26.7%[147] - Net profit for the year 2022 was RMB 2,583,747 thousand, compared to RMB 2,712,902 thousand in 2021, a decrease of 4.8%[147] - Foreign exchange translation differences resulted in a gain of RMB 632,886 thousand in 2022, compared to a loss of RMB 201,403 thousand in 2021[147] - Share-based payment reserves increased from RMB 134,062 thousand in 2021 to RMB 313,478 thousand in 2022, a growth of 133.8%[147] - Cash flow from operating activities in 2022 was RMB 2,741,205 thousand, up 6.4% from RMB 2,577,062 thousand in 2021[148] - Depreciation of right-of-use assets increased to RMB 315,538 thousand in 2022 from RMB 257,165 thousand in 2021, a rise of 22.7%[148] - Trade receivables and bills decreased by RMB 90,446 thousand in 2022, compared to an increase of RMB 549,347 thousand in 2021[148] - Inventory increased by RMB 40,943 thousand in 2022, a significant reduction from the RMB 111,747 thousand increase in 2021[148] - Contract liabilities increased by RMB 2,896 thousand in 2022, compared to a decrease of RMB 173,487 thousand in 2021[148] - Income tax paid in 2022 was RMB 324,033 thousand, slightly higher than the RMB 319,439 thousand paid in 2021[148] - Investment activities resulted in a net cash outflow of RMB 5,935,073 thousand in 2022, compared to RMB 2,259,157 thousand in 2021[149] - The company purchased equity investments measured at fair value through profit or loss for RMB 186,205 thousand in 2022, a decrease from RMB 357,266 thousand in 2021[149] - The company received interest income from bank deposits with initial deposit periods exceeding three months of RMB 111,172 thousand in 2022, down from RMB 150,170 thousand in 2021[149] - The company's cash and cash equivalents decreased by RMB 4,012,012 thousand in 2022, compared to an increase of RMB 3,734,681 thousand in 2021[149] - The company's year-end cash and cash equivalents stood at RMB 2,666,132 thousand in 2022, down from RMB 6,718,709 thousand in 2021[149] - The company's unrestricted cash and bank balances were RMB 2,464,318 thousand in 2022, slightly down from RMB 2,503,263 thousand in 2021[149] - The company's short-term unsecured time deposits with initial deposit periods of less than three months decreased to RMB 201,814 thousand in 2022 from RMB 4,215,446 thousand in 2021[149] - The company's financing activities resulted in a net cash outflow of RMB 818,144 thousand in 2022, compared to a net cash inflow of RMB 3,416,776 thousand in 2021[149] - The company paid dividends of RMB 712,184 thousand in 2022, up from RMB 380,866 thousand in 2021[149] ESG and Sustainability - The company's ESG performance was recognized with an MSCI ESG rating of 'A' and a score of 63 in the S&P Global Corporate Sustainability Assessment, surpassing 95% of global peers[4] - The company maintained an MSCI ESG rating of 'A' and scored 63 in the S&P Global Corporate Sustainability Assessment, ranking in the top 5% of global pharmaceutical peers[19] - The company scored 63 in S&P Global's Corporate Sustainability Assessment (CSA), ranking above 95% of global peers and earning multiple ESG awards, including being the only Chinese pharmaceutical company listed in the 2023 Sustainability Yearbook[40] Licensing and Partnerships - The company entered into an exclusive licensing agreement with NiKang Therapeutics in May 2022 to develop and commercialize NKT2152 in China (including Hong Kong, Macau, and Taiwan)[7] - The company signed an exclusive licensing agreement with TiumBio in August 2022 to develop and commercialize TU2670 for endometriosis and uterine fibroids in China (including Hong Kong, Macau, and Taiwan)[8] - The company secured global rights to develop, produce, and commercialize the anti-SARS-CoV-2 candidate drug GDI-4405 through an exclusive licensing agreement with GHDDI in August 2022[8] - The company entered into an exclusive licensing agreement with KiOmed in September 2022 to develop and commercialize KiOmedinevsOne for osteoarthritis in Mainland China, Macau, and Taiwan[9] - The company obtained exclusive rights to develop, produce, and commercialize the EGFR/cMet bispecific antibody drug PM1080 in China (including Hong Kong, Macau, and Taiwan) through a licensing agreement with Primus in November 2022[9] - The company entered into an exclusive licensing agreement with TiumBio in August 2022, securing rights to develop and commercialize TU2670 for endometriosis and uterine fibroids in China (including Hong Kong, Macau, and Taiwan)[36] - The company signed an exclusive licensing and co-development agreement with GHDDI in August 2022, gaining global rights to develop, produce, and commercialize the anti-SARS-CoV-2 candidate drug GDI-4405 series, which shows strong antiviral activity against Delta and Omicron variants[37] - The company partnered with KiOmed in September 2022, obtaining exclusive rights to develop and commercialize KiOmedinevsOne for osteoarthritis treatment in China (including Macau and Taiwan)[38] - The company signed a licensing agreement with Pu-Mu-Si in November 2022, securing exclusive rights to develop and commercialize PM1080, an EGFR/cMet bispecific antibody drug, in China (including Hong Kong, Macau, and Taiwan)[39] R&D and Innovation - The company's global headquarters and R&D center officially opened in December 2021, marking a new phase of innovation and internationalization[6] - The company has six innovative drugs approved in China, all included in the National Reimbursement Drug List[19][21] - Over 30 innovative drug projects are in various clinical stages, covering multiple therapeutic areas[19][21] - R&D personnel increased to 1,521 by the end of 2022[21] - The company completed the introduction of three clinical-stage products through licensing and collaboration[21] - The company's R&D investment totaled RMB 1.693 billion, accounting for 18.0% of total revenue[23] - The company's R&D team consists of 1,521 researchers across four R&D centers in Shanghai, Lianyungang, Changzhou, and the United States[30] - In 2022, Hengrui obtained 82 authorized patents in China (including 18 in Hong Kong, Macao, and Taiwan) and 10 foreign authorized patents[30] - Hengrui launched 11 new products in 2022, including the innovative drug Inebilizumab Injection (brand name: Xinyue®) for treating AQP4 antibody-positive NMOSD in adults[30] - The company submitted 6 new drug applications in 2022, including one innovative drug application (with new indications) for Pemostimotide Injection[30] - Hengrui received 19 clinical trial approvals in 2022, covering treatments for chronic myeloid leukemia, advanced solid tumors, schizophrenia, and menopausal vasomotor syndrome[32] - The company spent approximately RMB 292 million on BD projects (including upfront and milestone payments) in 2022[33] - The company will increase investment in R&D activities, leveraging internal and external cutting-edge technologies such as antibody-drug conjugates, small interfering RNA, and bispecific antibodies to expand its innovative therapy pipeline[44] Corporate Governance and Leadership - The Board of Directors consists of three executive directors (including the Chairman and CEO) and three independent non-executive directors as of December 31, 2022[47] - The Board has established five specialized committees, including Audit, Remuneration, Strategy and Development, ESG, and Nomination Committees, to oversee specific aspects of the company's operations[46] - The company has appointed three independent non-executive directors, with one possessing appropriate professional qualifications or expertise in accounting or financial management[48] - The Chairman and CEO roles are currently held by the same individual, Zhong Huijuan, due to her extensive knowledge and experience in the Chinese pharmaceutical industry, though the Board will consider separating the roles in the future[52] - Directors are required to retire and be re-elected at least once every three years, with one-third of the Board subject to re-election at each annual general meeting[53] - New directors receive comprehensive onboarding training, and the company encourages ongoing professional development to ensure informed contributions to the Board[55] - The company's audit committee reviewed the consolidated financial statements for the year ended December 31, 2022, and confirmed compliance with applicable accounting standards and listing rules[59] - The audit committee held two meetings in 2022 to review financial statements and internal audit effectiveness[60] - The remuneration committee held four meetings in 2022 to review executive and senior management compensation and restricted share unit grants[61] - The company granted restricted share units to certain employees, including two directors, with some units vesting in less than 12 months[61] - The strategy and development committee held one meeting in 2022 to assess development progress and future strategies, including exploring major investments and new market expansion[62] - The environmental, social, and governance (ESG) committee held two meetings in 2022 to review ESG initiatives and identify key ESG issues and climate change risks[63] - The Nomination Committee consists of three members, including one executive director and two independent non-executive directors, and held one meeting in 2022 to review the board's structure and independence[64] - The company has adopted a Board Diversity Policy, aiming to achieve diversity in professional experience, skills, knowledge, gender, age, cultural and educational background, race, and tenure[66] - As of December 31, 2022, the board includes six directors with an equal gender split, and the company's full-time employees consist of 64.2% male and 35.8% female[66] - The board held four meetings in 2022, and the chairman held one meeting with independent non-executive directors without other directors present[67] - All directors attended 100% of the board meetings, and the attendance rates for committee meetings and the annual general meeting were also 100%[68] - The company has five senior management employees, all of whom received compensation exceeding RMB 1.5 million in 2022[70] - The board confirms its responsibility for preparing financial statements that provide a true and fair view of the company's financial position, with no significant uncertainties affecting the group's ability to continue as a going concern[71] - The company has established a three-tier organizational framework (business units, functional departments, and internal control and audit departments) to identify, analyze, classify, control, and monitor risks related to strategy, operations, market development, financial matters, legal matters, investment and financing, information security, anti-bribery, and anti-money laundering[72] - The company paid a total of RMB 3,700 thousand to its external auditor, Ernst & Young, during the reporting period, including RMB 3,150 thousand for audit services and RMB 550 thousand for non-audit services[74] - The company has adopted a shareholder communication policy to ensure timely, comprehensive, and easily understandable information is provided to shareholders and investors through various channels, including market disclosures, the company's website, interim and annual reports, and shareholder meetings[75] - Shareholders holding at least one-tenth of the voting rights can request a general meeting, and if the board does not convene a meeting within 21 days, the requesting shareholders can convene the meeting themselves[76] - The company has not made any changes to its articles of association during the reporting period, and the latest version is available on the company's website and the Hong Kong Stock Exchange website[78] - The company's board has proposed a final dividend of 5 HK cents per share for the year ended December 31, 2022, bringing the total annual dividend to 10 HK cents per share, including the interim dividend[80] - The company's annual general meeting will be held on June 1, 2023, and the notice will be sent to shareholders at least 21 days before the meeting[82] - The company has 5,922,350,070 issued ordinary shares as of December 31, 2022[85] - The net proceeds from the placement in 2020 amounted to approximately HKD 3.4772 billion, with HKD 4.0027 billion utilized by December 31, 2022, and HKD 3.07693 billion remaining unused[86] - The net proceeds from the issuance of zero-coupon convertible bonds in 2021 amounted to approximately USD 595.